RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.

Patients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.

Biological: filgrastim

Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL.

Other Names:

Granulocyte Colony-Stimulating Factor

r-metHuG-CSF

G-CSF

Filgrastim

Neupogen

NSC # 614629

Drug: gemcitabine hydrochloride

Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8

Other Names:

Gemzar

NSC #613327

Drug: vinorelbine tartrate

Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8

Other Names:

Navelbine

NSC #608210

Detailed Description:

OBJECTIVES:

Determine the response rate of pediatric patients with recurrent or refractory Hodgkin's lymphoma treated with gemcitabine and vinorelbine.

Determine the toxicity of this regimen in these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5 years.

Eligibility

Ages Eligible for Study:

up to 30 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed Hodgkin's lymphoma* with any of the following histologies:

Not otherwise specified (NOS)

Mixed cellularity NOS

Lymphocytic depletion

NOS

Diffuse fibrosis

Reticular

Lymphocytic predominance

NOS

Diffuse

Nodular

Paragranuloma

Granuloma

Sarcoma

Nodular sclerosis

Cellular phase

NOS

Lymphocytic predominance

Mixed cellularity

Lymphocytic depletion NOTE: *Disease metastatic to bone marrow with granulocytopenia and/or thrombocytopenia is allowed, but is not evaluable for hematological toxicity

Measurable disease by clinical or radiographic criteria

Relapsed or refractory to conventional therapy

Received at least 2 prior cytotoxic chemotherapy regimens

No stage IA or IIA nodal disease previously treated with any of the following:

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070304